DBV Technologies

Data at AAAAI 2017 Show Lasting Response and Favorable Safety Profile of Investigational Agent, Viaskin Peanut, Throughout Three Years of Treatment of Peanut Allergic Children - Seite 2

The detailed results presented today show that progressive response to treatment was observed in children who received Viaskin Peanut 250 µg from the onset of therapy in VIPES. After completion of three years of treatment with the 250 µg dose, 83.3% of children in this subgroup responded to therapy compared to 53.6% at the completion of VIPES. At the end of OLFUS, cumulative reactive doses (CRDs) reaching 1,000 mg or more of peanut protein during the oral food challenge were observed in 61% of children receiving Viaskin Peanut 250 µg, which was double the number of patients reaching that CRD at the completion of VIPES. Furthermore, 39% of children reached CRD rates of 5,040 mg or more during the oral food challenge at the end of OLFUS. For reference, one peanut contains approximately 250 mg of peanut protein.

Over the 36-month study period, no treatment-related serious adverse events (SAEs) or epinephrine use was reported. In the overall population, the majority of adverse events reported were mild and moderate application-site skin reactions, for which severity and frequency were observed to decrease over time. Additionally, treatment compliance, which measures adherence to treatment dosing, remained high throughout the study at a median rate of 95.5%, and was not impacted by the dose of Viaskin Peanut administered or the age of patients enrolled in the study. At the end of OLFUS, the overall dropout rate due to adverse events remained low at 2.3%.   

Abstract #561                                   
Another oral presentation featured results from a study exploring peanut contamination cases in frequently consumed packaged foods, while assessing the potential clinical benefit of increasing an individual's degree of desensitization following treatment with immunotherapy. Presented by Dr. Joe Baumert, University of Nebraska, Food Allergy Research & Resource Program (FARRP), the study results suggested that peanut-allergic patients who can increase their peanut sensitivity thresholds following immunotherapy are at a much lower risk of having an allergic reaction from common packaged food items that may contain unknown traces of peanut.